Linaclotide for Chronic Constipation in Type 2 Diabetes

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Texas Tech University Health Sciences Center, El Paso

Must not be taking: Prokinetics, Opiates, Anti-spasmodics, NSAIDs

Disqualifiers: Pregnancy, Severe gastroparesis, Diverticulitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well linaclotide, a medication, manages chronic constipation in people with type 2 diabetes. Participants will receive either linaclotide or a placebo (inactive treatment) for 14 days, then switch to the other option after a break. It targets individuals with type 2 diabetes who have experienced constipation for at least six months, with symptoms like fewer than three bowel movements per week or difficulty during bowel movements. The study focuses on safety and effectiveness, with study staff closely monitoring participants. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires you to stop using certain medications, such as laxatives (except fiber or bulking agents), prokinetic agents, medications containing opiates, and anti-spasmodics, at least 3 days before starting and during the trial. If you are taking any of these, you will need to stop them to participate.

What is the safety track record for Linaclotide?

Research has shown that linaclotide is generally safe for use. The FDA has already approved it to treat irritable bowel syndrome with constipation and chronic constipation. Studies have found that doses of 145 micrograms and 290 micrograms are well-tolerated. Patients have reported improved bowel movements and fewer constipation symptoms. Some individuals might experience mild side effects, such as diarrhea, but overall, current data considers it safe. If there are any concerns, discussing them with a doctor before joining a trial is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about linaclotide for chronic constipation in people with type 2 diabetes because it offers a unique approach compared to standard treatments like fiber supplements, laxatives, or lifestyle changes. Unlike those options, linaclotide works by activating specific receptors in the gut to increase fluid secretion and accelerate bowel movements, offering relief more directly. This targeted mechanism can potentially provide faster and more effective results, which is why it’s gaining attention as a promising alternative for those who do not respond well to conventional treatments.

What evidence suggests that linaclotide might be an effective treatment for chronic constipation in type 2 diabetes?

Research has shown that linaclotide helps treat chronic constipation, particularly in people with type 2 diabetes. In this trial, participants will receive either linaclotide or a placebo for 28 days. One study found that linaclotide increased the number of complete bowel movements by about 2.5 times, leading to more regular and complete bowel movements. Linaclotide is generally safe, with few reported side effects. The FDA has approved it for conditions like irritable bowel syndrome with constipation and chronic constipation. Overall, linaclotide has consistently improved bowel habits and symptoms related to constipation. ^{1 2 3 4 6}

Who Is on the Research Team?

Irene Sarosiek, MD

Principal Investigator

Texas Tech University Health Sciences Center- El Paso, Texas

Are You a Good Fit for This Trial?

This trial is for Type II diabetics who've had chronic constipation for at least 6 months, with hard or lumpy stools. They should have less than three spontaneous bowel movements per week and not be using laxatives frequently. People with severe diseases, high hemoglobin A1c levels (>8.2), drug/alcohol abuse, certain gastrointestinal surgeries, or severe hemorrhoids can't join.

Inclusion Criteria

I have type II diabetes.

I have been constipated for at least 6 months.

I have had constipation for over 6 months with hard stools and often feel incomplete after going.

Exclusion Criteria

I regularly take NSAIDs more than three times a week.

I struggle significantly with bowel movements due to pelvic floor issues.

I do not have any severe illnesses that my doctor thinks should keep me out of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive either linaclotide or placebo for 14 days

2 weeks

2 visits (in-person)

Washout

A 2-week break without medication to separate treatment phases

2 weeks

Treatment Phase 2

Participants receive the alternate treatment (linaclotide or placebo) for 14 days

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Linaclotide

Trial Overview The study tests Linaclotide against a placebo in people with diabetes and chronic constipation over two phases of 14 days each, separated by a two-week break. Participants are randomly assigned to start with either the active drug or placebo and then switch after the break.

How Is the Trial Designed?

Group I: 1)28days of linaclotide or placebo Active Control 1 Intervention

patient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study.

Group II: 2)28days of linaclotide or placebo Active Control 1 Intervention

patient will be randomized and allocated to one of the treatment arms using computerized generated simple random number in a double-blinded fashion for 28 days of therapy with the study drug, linaclotide or placebo. Patients, and trial personnel involve (other than biostatistician) in this study will not be aware of the group assignments. Patients, treatment providers and staffs will be kept blinded in this study.

Linaclotide is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Linzess for:

• Chronic idiopathic constipation
• Irritable bowel syndrome with constipation (IBS-C)
• Functional constipation in pediatric patients 6 to 17 years of age

Approved in European Union as Constella for:

• Chronic idiopathic constipation
• Irritable bowel syndrome with constipation (IBS-C)

Approved in Canada as Linzess for:

• Chronic idiopathic constipation
• Irritable bowel syndrome with constipation (IBS-C)
• Functional constipation in pediatric patients 6 to 17 years of age

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center, El Paso

Lead Sponsor

Trials

51

Recruited

5,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03119584

NCT03119584 | Efficacy of Linaclotide in Type II Diabetics ... Constipation has been reported as a common complication of diabetic neuropathy. A new medication, called linaclotide, was studied on many patients, and it is ...

2. journals.lww.com journals.lww.com/ajg/fulltext/2017/10001/efficacy_of_linaclotide_in_type_ii_diabetics_with.119.aspx

Efficacy of Linaclotide in Type II Diabetics With Chronic... This study indicates that linaclotide 145 μg QD is a safe and effective treatment for DM-CC significantly increasing CSBMs (approx. 2.5 fold) and improving ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8531776/

Comparison of the Efficacy and Safety of Different Doses ... Linaclotide at doses of 145 μg and 290 μg has demonstrated an adequate level of safety and efficacy in two large RCTs conducted on CC patients [ ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK578208/

Linaclotide - StatPearls - NCBI Bookshelf Linaclotide is an FDA-approved medication indicated for adults suffering from irritable bowel syndrome with predominant constipation (IBS-C) and chronic ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016508509022471

Efficacy of Linaclotide for Patients With Chronic Constipation Linaclotide therapy was associated with few adverse events and produced rapid and sustained improvement of bowel habits, abdominal symptoms, global relief, and ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nmo.14938

Efficacy and safety of linaclotide in treatment‐resistant ... Linaclotide improved the JPAC-QOL total score, bowel movement frequency, stool consistency, abdominal bloating, and straining in patients ...